Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210724
Company: AM REGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYPROGESTERON CAPROATE HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription AP1 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/09/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

HYDROXYPROGESTERON CAPROATE

SOLUTION;INTRAMUSCULAR; 1250MG/5ML (250MG/ML)
TE Code = AP1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROXYPROGESTERON CAPROATE HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AP1 210724 AM REGENT
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AP1 211070 EUGIA PHARMA
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AP1 210618 SLAYBACK PHARMA LLC
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AP1 208381 SUN PHARM
MAKENA HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION;INTRAMUSCULAR Prescription Yes AP1 021945 AMAG PHARMA USA

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